Glycemic Response in Persons With Type 2 Diabetes Mellitus

November 18, 2019 updated by: Société des Produits Nestlé (SPN)

Plasma Glucose and Insulin Response to Six Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus

This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Tustin, California, United States, 92780
        • Orange County Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Subject inclusion criteria

All subjects must comply with all the following inclusion criteria:

  • Age 20-75 years
  • Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
  • Hemoglobin A1C less than 9.0%
  • Fasting blood glucose less than 180 mg
  • Hematocrit levels within normal limits
  • Having obtained his/her informed consent

Subject exclusion criteria Subjects representing one or more of the following criteria are excluded from participation in the study.

  • Abnormal thyroid function
  • Creatinine >2.0 mg/dl
  • Potassium <3.5 mEq/l
  • Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
  • Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
  • Unable to give informed consent or follow instructions
  • Current insulin therapy or insulin therapy within the past month
  • Patient who are pregnant
  • Allergies to milk, soy or any component of the test product
  • Patient who in the investigators assessment cannot be expected to comply with treatment
  • Currently participating or having participated in another clinical trial
  • Patients with anemia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oral Nutrition Supplement A
Product containing calories from carbohydrate, protein, and fat
Other: Oral Nutrition Supplement
Product intake of oral nutrition supplement provided
Active Comparator: Oral Nutrition Supplement B
Product containing calories from carbohydrate, protein, and fat
Other: Oral Nutrition Supplement
Product intake of oral nutrition supplement provided
Active Comparator: Oral Nutrition Supplement C
Product containing calories from carbohydrate, protein, and fat
Other: Oral Nutrition Supplement
Product intake of oral nutrition supplement provided
Active Comparator: Oral Nutrition Supplement D
Product containing calories from carbohydrate, protein, and fat
Other: Oral Nutrition Supplement
Product intake of oral nutrition supplement provided
Active Comparator: Oral Nutrition Supplement E
Product containing calories from carbohydrate, protein, and fat
Other: Oral Nutrition Supplement
Product intake of oral nutrition supplement provided
Active Comparator: Oral Nutrition Supplement F
Product containing calories from carbohydrate, protein, and fat
Other: Oral Nutrition Supplement
Product intake of oral nutrition supplement provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the blood glucose curve (ACU 0-240 minutes)
Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the insulin curves (AUC 0-240)
Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Insulinogenic index [Change in Ins30/Change in Glu30]
Time Frame: [Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]
[Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2018

Primary Completion (Actual)

April 18, 2018

Study Completion (Actual)

April 18, 2018

Study Registration Dates

First Submitted

February 1, 2018

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 19, 2019

Study Record Updates

Last Update Posted (Actual)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17.11.US.HCN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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